SCA Pharmaceuticals, LLC – FDA Warning Letter, Oct 30, 2025

The FDA issued a formal warning letter to SCA Pharmaceuticals, LLC following an inspection of its Little Rock, Arkansas, facility from October 20 to October 30, 2025. Although registered as an outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act, the company failed to maintain the required standards for sterile drug production, leading to products being classified as adulterated. The investigation identified several serious issues, primarily involving "insanitary conditions" and failures to follow Current Good Manufacturing Practice (CGMP). Specific violations included inadequate airflow testing in sterile work zones, poor hygiene and handling techniques by staff that risked contamination, and a failure to thoroughly investigate microbial findings. Additionally, the facility was cited for allowing foreign materials, such as cardboard fragments, to remain in syringe components and for failing to retain essential production video recordings needed for quality oversight. The FDA determined that previous corrective actions submitted by the company were insufficient. SCA Pharmaceuticals is required to provide a written response within 15 working days detailing the specific steps taken to address these violations and prevent their recurrence. The FDA also strongly recommends that the company hire an independent consultant to conduct a comprehensive assessment of their aseptic processing operations to ensure the safety and quality of their drug products.